drugset / Trial / NCT01938846

BI 860585 Dose Escalation Single Agent and in Combination With Exemestane or With Paclitaxel in Patients With Various Advanced and/or Metastatic Solid Tumors

NCT01938846

Phase 1 Completed 90 enrolled Boehringer Ingelheim
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the trial is to determine the maximum tolerated doses (MTD) of BI 860585 alone and in combination with exemestane or paclitaxel. To determine the MTDs, patients are entered sequentially into escalating dose cohorts. Secondary objectives are objective response and disease control according to RECIST criteria version 1.1

Timeline

Start
2013-09-05
Primary completion
2016-07-30
Completion
2017-06-22

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 860585 Unknown Oral
Background Exemestane Small molecule
Background Paclitaxel Small molecule

Indications